DEAR DR. ROACH:
I have seen news reports of many positive results from people using INNOVO, the FDA-approved shorts that provide electrical pelvic muscle stimulation, to possibly eliminate incontinence entirely. I also have heard that insurance companies may help pay the cost of these shorts. Since this may help many of your readers, can you comment on this product, which I’ve heard described as a “life-changer” from many of its users? — Anon.
ANSWER:
The INNOVO device uses electricity to contract the pelvic muscles and strengthen them — a similar mechanism to doing pelvic floor (Kegel) exercises, which some women have difficulty doing. (Although both men and women may develop stress incontinence, the device is only for use in stress incontinence with women.) I wish I were as enthusiastic as you are about it, since more non-medication therapies for incontinence are definitely needed, but there are several points I need to clarify.
First, the INNOVO device is not FDA-approved. INNOVO is a Class II medical device, for which the FDA doesn’t require approval. Approval is given for devices deemed to be “higher risk,” and consequently, the FDA requires an extensive safety evaluation before a Class III device can be approved for use. The INNOVO device is “FDA cleared” and does not require a prescription.
I reviewed the studies examining the effectiveness of the device. Although some studies showed no difference between the INNOVO device and a placebo device that did not provide electrical stimulation, the studies that did showed a moderate benefit. One study noted 37% of women assigned to the INNOVO device found at least 50% improvement in leakage episodes, compared to 12% of women using the placebo device.
I did not find any study that showed an improvement in eliminating incontinence entirely compared to a placebo device. The device has not been shown to be better than pelvic floor exercises, which remains a preferred treatment.
I have no experience with…
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